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MYOHERTAX: Myocet, Trastuzumab, and Docetaxel in HER2+ Metastatic Breast Cancer

NCT00377780Phase 2

Key facts

Status: Terminated
Start: Aug 2006
Primary completion: Aug 2015
Countries: 1
Sponsor: Laurence J.C. van Warmerdam
Modality: DNA Intercalators/Alkylators

Drugs: doxorubicin
Conditions: breast cancer

Overview

Phase 2, open-label, single-arm trial of doxorubicin in breast cancer, sponsored by Laurence J.C. van Warmerdam. Primary endpoints: Cardiotoxicity (definite or probable cardiac death), Signs or symptoms of congestive heart failure (CHF), NYHA class III-IV and 1 more. Started Aug 2006; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Myocet + docetaxel + trastuzumab
Non-pegylated liposomal doxorubicin, trastuzumab, and docetaxel combination

Who it enrols

Women >= 18 years with HER2+ metastatic or locally advanced breast cancer, no prior chemotherapy for metastatic disease, normal LVEF, and adequate organ function.

Endpoints

Primary

Cardiotoxicity (definite or probable cardiac death)treatment period
Signs or symptoms of congestive heart failure (CHF), NYHA class III-IVtreatment period
Decline in left ventricular ejection fraction (LVEF)treatment period

Secondary

Frequency and severity of intercurrent eventstreatment period
Response ratetreatment period
Median time to progressiontreatment period
Progression free survivaltreatment period

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